Trial Comparing Capecitabine Plus Oxaliplatin (XELOX) and Capecitabine (X) as First-line Chemotherapy in Elderly Patients With Advanced Gastric Cancer
This study is currently recruiting participants.
Verified June 2013 by Samsung Medical Center
Sponsor:
Samsung Medical Center
Information provided by (Responsible Party):
Won Ki Kang, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01470742
First received: November 7, 2011
Last updated: June 12, 2013
Last verified: June 2013
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Purpose
The objective of the trial is to compare Overall survival between capecitabine plus oxaliplatin (XELOX) and capecitabine (X) as first-line chemotherapy in elderly patients with advanced gastric cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastric Cancer |
Drug: XELOX Drug: XELODA |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized, Phase III, Multicenter Clinical Trial Comparing Capecitabine Plus Oxaliplatin (XELOX) and Capecitabine (X) as First-line Chemotherapy in Elderly Patients With Advanced Gastric Cancer |
Resource links provided by NLM:
Further study details as provided by Samsung Medical Center:
Primary Outcome Measures:
- Overall survival of XELOX(XELODA/oxaliplatin) vs X(XELODA) [ Time Frame: 36months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- response rate [ Time Frame: 36months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 200 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | January 2015 |
| Estimated Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: XELODA
Capecitabine 1000mg/m2 bid D1-14 every 3weeks
|
Drug: XELODA
Capecitabine 1000mg/m2 bid D1-14 every 3weeks
|
|
Experimental: XELOX
D1-14 Capecitabine 1000mg/m2 bid D1 Oxaliplatin 110mg/m2 + D5W 250ml over 2hr every 3weeks
|
Drug: XELOX
D1-14 Capecitabine 1000mg/m2 bid D1 Oxaliplatin 110mg/m2 + D5W 250ml over 2hr every 3weeks
|
Eligibility| Ages Eligible for Study: | 70 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age ≥ 70
- Histologically or cytologically confirmed adenocarcinoma of the gastric
- Advanced ,metastatic/recurrence gastric cancer
- ECOG performance status of 0 to 2
- Life expectancy≥3months
- No history of any systemic anti-cancer chemotherapy (prior adjuvant chemoradiation or chemotherapy is allowed if the last date of drug administration is > 6months from the study entry date)
- No history of radiation therapy about Target lesion. (Prior radiotherapy is permitted if it was not administered to target lesions selected for this study, unless progression of the selected target lesions within the radiation portal is documented, and provided it has been completed at least 4 weeks before randomization.
- Adequate marrow functions (ANC ≥ 1,500/uL, PLT ≥100,000/uL)
- Adequate renal functions (Creatinine ≤1.5mg/dL or Ccr ≥ 50ml/min)
- Adequate hepatic functions ( bilirubin ≤ 2.0mg/dL, SGOT/SGPT < normal x 3)
- provision of a signed written informed consent
Exclusion Criteria:
- History of any medical or psychiatric condition
- Active infections
- Peripheral neuropathy with symptom(NCI-CTCAE ver. 3.0 >=Grade 1 )
- symptomatic brain metastases
- Double primary cancer (physician at the discretion of the other cancer cured the purpose of early cancer cases can be registered)
History of other malignancy except:
Adequately treated non-melanomatous skin cancer or cervical carcinoma in situ
- Known hypersensitivity to Fluoropyrimidines/platinum
- Clinical significant cardiovascular disease (myocardial infarction, symptomatic coronary artery disease, congestive heart failure, severe arrhythmias)
- Required immunosuppressive therapy(transplant patients, severe autoimmune disease)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01470742
Contacts
| Contact: mi yeon kwon, RN | 82-2-3410-1248 |
Locations
| Korea, Republic of | |
| Samsung medical Center | Recruiting |
| Seoul, Korea, Republic of, 135-710 | |
| Contact: Mi yeon kwon, RN +82-2-3410-1248 | |
Sponsors and Collaborators
Samsung Medical Center
More Information
No publications provided
| Responsible Party: | Won Ki Kang, Professor of Medicine, Sungkyunkwan University School of Medicine, Department of Hematology and Oncology, Samsung Medical Center |
| ClinicalTrials.gov Identifier: | NCT01470742 History of Changes |
| Other Study ID Numbers: | 2010-04-118 |
| Study First Received: | November 7, 2011 |
| Last Updated: | June 12, 2013 |
| Health Authority: | Korea: Food and Drug Administration |
Additional relevant MeSH terms:
|
Stomach Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Stomach Diseases Oxaliplatin Capecitabine |
Fluorouracil Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 18, 2013